FDA 510(k) Application Details - K181870

Device Classification Name	Set, Administration, Intravascular   More FDA Info for this Device
510(K) Number	K181870
Device Name	Set, Administration, Intravascular
Applicant	Wuhan W.E.O Science & Technology Development Co., Ltd. No.18, Huanhu Mid. Rd., Jinyin Lake, Dongxihu Dist Wuhun 430040 CN Other 510(k) Applications for this Company
Contact	Chengling Fu Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/12/2018
Decision Date	02/26/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review